Cleared Traditional

K113045 - BIOHARNESS

K113045 is an FDA 510(k) clearance for BIOHARNESS, manufactured by Zephyr Technology Corporation. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K113045 · Zephyr Technology Corporation · Cardiovascular device
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Aug 2012
Decision
306d
Days
Class 2
Risk

K113045 is an FDA 510(k) clearance for the BIOHARNESS. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Zephyr Technology Corporation (Stamford, US). The FDA issued a Cleared decision on August 14, 2012 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Zephyr Technology Corporation devices

FDA 510(k) Submission Details - K113045

510(k) Number K113045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2011
Decision Date August 14, 2012
Days to Decision 306 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 125d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 338
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K113045.
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K120173 · Edan Instruments, Inc. · May 2012